Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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IN THE CASE OF | |
Hertiage Manor of Columbia, |
DATE: January 15, 2003 |
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Centers for Medicare & Medicaid
Services.
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Docket No.C-02-848 Decision No. CR995 |
DECISION | |
DECISION I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to terminate the participation in the Medicare program of Petitioner, Heritage Manor of Columbia. I base this decision on my conclusion that Petitioner failed to comply substantially with two Medicare participation requirements. I. Background Petitioner is a skilled nursing facility that is located in Columbia Tennessee. It has participated in the Medicare program. The participation in Medicare of facilities like Petitioner is governed by regulations at 42 C.F.R. Parts 483, 488, and 498. On September 4 and 5, 2002 (September survey), surveyors employed by the Tennessee Department of Health surveyed Petitioner to determine whether Petitioner was complying with Medicare participation requirements. The surveyors concluded that Petitioner was not complying substantially with nine specific Medicare participation requirements. CMS concurred with these findings and determined to terminate Petitioner's participation in Medicare. Petitioner requested a hearing. At a previous survey completed in August 2002 (August survey) surveyors concluded that Petitioner also was failing to comply substantially with numerous Medicare participation requirements. CMS determined to impose remedies based on those findings that are in addition to the termination of participation that is at issue here. Petitioner requested a hearing concerning these other remedies and the case was docketed as Civil Remedies Docket No. C-02-849. It is my normal practice to consolidate cases involving different surveys and the same facility so that I may hear and decide them more efficiently. I have not done so here in order that I may issue an expedited decision that addresses only the termination of participation issue. I note that, as a consequence of the August survey, CMS imposed remedies against Petitioner which included civil money penalties of $3,750 per day for each day beginning with August 15, 2002. CMS subsequently determined that those penalties should continue through September 5, 2002, based in part on the results of the September survey. As I discuss above, I am not at this time deciding whether remedies were appropriate based on the results of the August survey. Nor am I deciding the duration of those remedies including the question of whether civil money penalties in any amount should continue up through completion of the September survey. Obviously, my decision in this case holds that Petitioner was not complying substantially with two participation requirements as of the September survey. I am deferring at this time deciding the scope and severity of these two deficiencies beyond holding that they were substantial because it is unnecessary that I do so to address the issue of whether CMS has the authority to terminate Petitioner's participation in Medicare. My intent is to address that question and to deal with the issue of the amount and duration of civil money penalties in a subsequent decision in which I also address the deficiency findings that were made at the August survey. I conducted an expedited hearing in Nashville, Tennessee, on October 22, 2002. At the hearing I received into evidence exhibits from CMS consisting of CMS Ex. 17 - CMS Ex. 43 and CMS Ex. 47 - CMS Ex. 52. I received into evidence exhibits from Petitioner consisting of P. Ex. 1 - P. Ex. 43. I heard cross-examination and redirect testimony of several witnesses (I received these witnesses' written direct testimony as part of the exhibits that I received into evidence). Prior to the hearing Petitioner filed two motions addressing legal issues. It moved that I reject the noncompliance allegations made at Tag 309 of the report of the September survey on the ground that the regulation to which these allegations relate - 42 C.F.R. � 483.25 - is so vaguely worded that it fails to establish criteria against which Petitioner's compliance may be measured. And, it asserted that the Departmental Appeals Board had unfairly assigned to Petitioner the burden of proving its compliance with participation requirements. I denied these motions on the record of the hearing. Tr. at 8 - 11. II. Issue, findings of fact and conclusions of law
The issue in this case is whether, as of September 5, 2002, Petitioner was not complying substantially with one or more federal participation requirements, thereby authorizing CMS to terminate Petitioner's participation in Medicare.
I make findings of fact and conclusions of law (Findings) to support my decision. I set forth each Finding below, as a separate heading. I discuss each Finding in detail.
As I discuss above, CMS determined to terminate Petitioner's participation in the Medicare program based on its conclusion that, as of September 5, 2002, Petitioner was not complying substantially with nine separate Medicare participation requirements. CMS concluded that the level of Petitioner's noncompliance with several of these requirements was so serious as to comprise immediate jeopardy for residents of Petitioner. To conclude that CMS is authorized to terminate Petitioner's participation in Medicare, I need not decide that Petitioner failed to comply with every one of the nine participation requirements alleged by CMS. As a matter of law, CMS is authorized to terminate a skilled nursing facility's participation in Medicare if that facility fails to comply substantially with just one Medicare participation requirement. Social Security Act (Act), section 1866(b)(2)(A). Nor is it necessary for me to decide that Petitioner's noncompliance with any of the nine requirements that are at issue was so severe as to put residents at immediate jeopardy. Id. A basis to find failure to comply substantially with a participation requirement exists if it is shown that the noncompliance poses a potential for more than minimal harm to residents of a facility. 42 C.F.R. � 488.301.
In this Finding I analyze the evidence that pertains to each of the nine participation requirements with which Petitioner allegedly failed to comply substantially as of the September survey. I decide that Petitioner failed to comply substantially with two participation requirements. These requirements are stated at 42 C.F.R. � 483.25(c), (pressure sores), and at 42 C.F.R. � 483.25(l)(1) (unnecessary drugs). In all other respects, Petitioner either complied substantially with participation requirements or CMS failed to establish a prima facie case that Petitioner did not comply.
At Tag 223 of the report of the September survey the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.13(b). The regulation provides that a resident of a facility has the right to be free from verbal, sexual, physical, and mental abuse, corporal punishment, and voluntary seclusion. The word "abuse" is defined at 42 C.F.R. � 488.301 to mean:
The surveyors alleged that Petitioner allowed one of its employees, a licensed practical nurse, to "yell" at and to threaten a resident and to talk roughly to two other residents. Additionally, the employee in question is alleged to have administered insulin to a resident without simultaneously offering food to that resident and to have brought a breakfast tray late to that same resident. The surveyors alleged also that these alleged acts of abuse violated a plan of correction in which Petitioner pledged that it would have zero tolerance of abuse. CMS Ex. 21 at 1 - 2. I am not persuaded that these allegations make out a prima facie case that Petitioner tolerated abuse at its facility. I find the allegations not to be credible because they rely entirely on hearsay complaints of residents that are unsupported by any corroborating evidence. Furthermore, the allegations of abuse are vague and fail to describe the allegedly abusive speech with sufficient clarity so that I might decide whether the allegedly abusive speech and conduct, even if it occurred, was actually "willful infliction of injury." See 42 C.F.R. � 488.301. I routinely admit hearsay evidence in hearings involving CMS. The traditional reason for not admitting hearsay - that members of a jury might be prejudiced by evidence that is inherently unreliable - is not a factor in these cases. However, the fact that I admit hearsay does not mean that I find it necessarily to be credible. There are valid reasons which underlie a general rule of evidence against admitting hearsay. Much hearsay is unreliable. I find that to be the case with the hearsay statements that support the allegations that are the basis for Tag 223 of the September survey report. The principal problem with relying on the hearsay complaints of residents is that there is no viable way to test the credibility of these residents' statements. These are individuals who, by definition, are too ill to be able to move about freely in public. It would hardly be realistic to subject these individuals to rigorous cross-examination. Consequently, if CMS is to rely on hearsay as support for its contentions, it needs to buttress such statements with corroborative evidence that either enhances the reliability of the hearsay or provides independent support for those contentions. CMS has provided nothing of that sort here. The hearsay statements of Resident # 17 are the principal support for the abuse allegations that are made at Tag 223. The statements of Resident # 17 are neither inherently credible nor supported by corroborating evidence. Far from being buttressed, the statements are vitiated by evidence which shows the resident to be an unreliable reporter. The resident suffers from emotional problems that call into serious question the veracity of her complaints. On August 27, 2002, just one week prior to the survey, a psychologist found the resident to be anxious, ruminating, tearful, and to display delusional thinking. P. Ex. 6, at 1. The psychologist observed that the resident:
Id. at 2. Additionally, I have no idea from the hearsay accounts in the survey report exactly what the alleged statements by the nurse were that prompted the residents' complaints. There is no description of the circumstances in which the statements allegedly were made. Thus, I cannot tell what the complaining residents meant when they alleged that the nurse yelled, threatened, or talked roughly. It is not clear from the report whether the allegedly abusive speech - assuming that the nurse uttered anything that could be characterized as uncivil or inappropriate - was directed at specific residents or was intended to intimidate them. Finally, some of the conduct alleged by the complaining residents is not, on its face, abusive even if it occurred. I can discern no reason why administering insulin without simultaneously providing food or bringing a breakfast tray late should be characterized as abuse in the absence of any evidence of the allegedly offending nurse's intent. CMS has offered no prima facie evidence that the complained-of care even violated accepted standards of care in administering insulin. And, it has offered nothing to show why this conduct, assuming it to have occurred, evidences willful efforts to injure a resident.
At Tag 280 of the report of the September survey the surveyors alleged that Petitioner was not complying substantially with the requirements of 42 C.F.R. � 483.20(k)(2). This regulation states that, for each resident of a facility:
The allegations of noncompliance in the survey report center on the care that Petitioner provided to five of its residents, who are identified as Residents #s 7, 8, 9, 11, and 19. CMS Ex. 21 at 2 - 6. The report asserts that Petitioner failed adequately to revise the care plans of these residents. Id. at 2, 4. The specific allegations are that:
I find that the survey report's allegations with respect to Residents #s 9 and 11 do not state a prima facie case that Petitioner failed to comply with the requirements of 42 C.F.R. � 483.20(k)(2). Many of the allegations concerning Petitioner's alleged failure to give care to these residents are irrelevant to the question of whether Petitioner revised the residents' plans of care in accord with the requirements of the regulation. The regulation does not address documentation of nurses' or physicians' notes or orders, or updates of activities of daily living flow sheets. Consequently, Petitioner's alleged failure to maintain or update such documents is not reason to conclude that it failed to update timely its residents' plans of care. Nor does the regulation address directly the care that a facility gives to its residents. Arguably, Petitioner should have provided treatment to Residents #s 9 and 11 as soon as problems were brought to Petitioner's staff's attention by the surveyors. But, the alleged failure of Petitioner to provide that care is irrelevant to the issue raised under Tag 280, which is whether Petitioner made updates to these residents' plans of care in accordance with the requirements of 42 C.F.R. � 483.20(k)(2). The allegations that are made concerning Residents #s 9 and 11 which are relevant - that Petitioner failed timely to update these residents' plans of care - fail because CMS has not established the criteria that a facility must follow in updating care plans. I infer from the survey report that the surveyors, and CMS, are alleging that Petitioner violated the requirements of 42 C.F.R. � 483.20(k)(2) because it did not update the care plans of Residents #s 9 and 11 immediately after the surveyors advised Petitioner's staff that the residents had developed pressure sores. But, the regulation contains no such requirement. It merely states that care plans must be reviewed and revised "periodically." 42 C.F.R. � 483.20(k)(2)(iii). Absent any definition of the term "periodically" one logically would look to applicable standards of nursing care in order to decide what the term means in the context of development of a new pressure sore by a facility resident. But, CMS has provided no evidence as to what comprises the applicable standard. I can discern nothing in the record of this case to suggest that a facility would be remiss if it waited more than 24 hours to revise a resident's plan of care after the facility's staff learned that the resident had developed a pressure sore. Moreover, the regulation suggests that revisions to plans of care need not be made instantaneously or nearly so. The regulation requires that plans of care be reviewed and revised periodically "by a team of qualified persons after each assessment." 42 C.F.R. � 483.20(k)(2)(iii). That language suggests that a care plan revision needs to be made after a thorough review by a team of medical professionals. The language does not suggest that such teams can or should be convened on very short notice to address every problem that a resident may manifest. I find that Petitioner rebutted, by the preponderance of the evidence, the allegations of noncompliance that the surveyors made with respect to Residents #s 7 and 8. Petitioner produced plan of care revisions for Residents #s 7 and 8, showing that each of these residents' plans of care had been reviewed and revised shortly prior to the September survey. P. Ex. 12; P. Ex. 41, at 12. As for Resident # 19, CMS introduced no evidence to support the statement in the report of the September survey that the resident had developed a pressure ulcer within the two weeks prior to the survey. See CMS Ex. 21, at 5. This allegation is thus uncorroborated and unsubstantiated. However, Petitioner introduced evidence showing that the resident denied that she had developed a pressure ulcer. P. Ex. 11. More significantly, the resident's charge nurse averred that, to her knowledge, the resident had never experienced a skin breakdown. Id.; see P. Ex. 41, at 11. >From this evidence I conclude that Petitioner was not remiss in its care planning for Resident # 19.
At Tag 281 of the report of the September survey the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.20(k)(3)(i). CMS Ex. 21, at 6 - 8. The regulation mandates that the services that are provided by a facility must meet professional standards of quality. The surveyors asserted that Petitioner failed to meet professional standards of quality in providing care to three residents, identified in the survey report as Residents #s 3, 19, and 20. Id. at 6. The surveyors made the following allegations with respect to the care that Petitioner gave to these three residents.
The allegations that were made with respect to Resident # 3 do not establish a prima facie case that Petitioner failed to provide care that met accepted standards of quality as of September 5, 2002. First, it is unclear from these allegations exactly what it is that Petitioner did or failed to do in providing care to the resident that did not comply with accepted standards of quality. CMS has not offered any prima facie proof to establish what documentation standards would apply to a resident who was suffering from the ailments that beset Resident # 3. Nor has it offered prima facie evidence that Petitioner was derelict in providing care to the resident. The surveyors' summary of events suggests that Petitioner's staff was diligent in attempting to contact the resident's physician when the resident's condition worsened beginning on January 10, 2002. It is unclear from the survey report that accepted standards of care would have required Petitioner's staff to attempt to notify the physician sooner. Nor has CMS pointed to evidence that is independent from the survey report that would support a conclusion that Petitioner was remiss in providing care to the resident. Significantly, the events described in the survey report pertaining to Resident # 3 occurred in January 2002, nearly eight months prior to the September survey. I find that these events - even if they arguably show some failure to provide care that met accepted standards of care - are so remote in point of time as to say nothing meaningful about the quality of care that Petitioner was providing in September 2002. I also conclude that the allegations that are made with respect to the care that Petitioner provided to Residents #s 19 and 20 do not establish a prima facie case of noncompliance with the requirements of the regulation. There is nothing in the regulation that requires that pain management flow sheets be completed for residents of a facility who complain of pain daily. Moreover, a failure by Petitioner to comply with its plan of care or its own internal policies is not, per se, a violation of a regulation. Arguably, professionally recognized standards of nursing care might require that such sheets, or something like them, be completed. But, CMS has offered no prima facie evidence that such is required. Moreover, CMS has offered no prima facie evidence that the residents failed to receive medications when needed, or that Petitioner's staff was inattentive to the residents' complaints of pain. Although CMS did not prove a prima facie case that Petitioner was deficient in the pain management care that it gave to Residents #s 19 and 20, Petitioner offered evidence to show that it was attentive to the residents' needs, including documenting administration of pain medications to the residents. P. Ex. 15; P. Ex. 16; P. Ex. 41, at 13 - 14.
At Tag 309 of the report of the September survey the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.25. CMS Ex. 21, at 8 - 10. The regulation requires a facility to provide each of its residents with the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with that resident's comprehensive assessment and plan of care. The surveyors alleged that Petitioner failed to provide care and services to one resident - identified in the survey report as Resident # 21 - that were necessary to maintain the resident's highest practicable physical, mental, and psychosocial well-being. According to the surveyors, the resident suffered from a severe decline during the week preceding the September survey. Id. at 10. They asserted that Petitioner failed to assess the resident's allegedly severe decline in a timely manner and failed to administer treatments that were prescribed by the resident's physician. Id. To support these assertions the surveyors made the following allegations of fact:
The surveyors relied heavily on uncorroborated hearsay accounts to depict Resident # 21's condition as declining precipitously without intervention by Petitioner's staff in the week that preceded the September survey. I do not find these accounts credible because they are unverified hearsay. There is simply no way to ascertain the credibility of the anonymous member of the resident's family who asserted that the resident had suffered a major decline in the week prior to the survey. Equally, it is impossible to ascertain the credibility of the account that the anonymous family member attributed to a second anonymous family member. Indeed, the allegations that the resident suffered a precipitous and unassessed decline while under Petitioner's care are not supported by the credible evidence of record. In that regard I find to be persuasive the opinion expressed by Gibran Naddy, M.D., the resident's treating physician, and Petitioner's medical director, that Resident # 21 did not suffer a severe decline that Petitioner failed to assess. P. Ex. 39, at 2. There are some allegations at Tag 309 of the survey report that I find to be credible. These are the allegations that Petitioner's staff failed to record the resident's vital signs after being instructed specifically to do so by the resident's treating physician, and failed to administer antibiotics to the resident immediately after they were prescribed. These assertions are based on reviews of the resident's record at Petitioner's facility. However, close review of the evidence fails to establish grounds for concluding that Petitioner was derelict in providing care to Resident # 21. Petitioner has not disputed the assertion that its staff failed to record the resident's vital signs between the evening of September 3, 2002 and September 4. However, there is no evidence in this case from which I can gauge the significance of this failure. Consequently, I cannot conclude that the failure to record the resident's vital signs posed a potential for more than minimal harm to the resident. The applicable regulation - 42 C.F.R. � 483.25 - contains no standard that defines what a facility must do to provide "necessary" care that enables a resident to attain the maximum level of physical, mental, and psychosocial well-being. In fact, Petitioner premised its motion to dismiss the allegations that were made at Tag 309 of the September survey report on the failure of the regulation to define "necessary." In denying that motion I held that the absence of an explicit definition in the regulation did not mean that the regulation was defective. It meant that professionally accepted standards of care are incorporated into the regulation to define what would be necessary in a particular situation. Failure to provide care that professionally recognized standards of nursing define as necessary would be a substantial violation of the regulation. See 42 C.F.R. � 488.301. The absence of a specific standard in the regulation imposes on CMS a duty to explain what the applicable standard of care consists of. That obligation is part of CMS's overall duty to present a prima facie case of noncompliance. As an element of this duty CMS must make a prima facie showing that any noncompliance it identifies is substantial. CMS did not meet its obligations here. Evidence is lacking to show what are the professionally recognized standards of care that govern a facility's obligation to take a resident's vital signs. Is failure to record Resident # 21's vital signs between the evening of September 3, 2002 and the morning of September 4, 2002 a violation of accepted nursing standards? CMS has offered no affirmative proof to establish that, in the context of this case and given the clinical evidence relating to this resident, failure to record the resident's vital signs during the time period at issue posed a potential for more than minimal harm to the resident. For these reasons I cannot infer that Petitioner's failure to record the vital signs of Resident # 21 during the evening of September 3, 2002 and the morning of September 4, 2002 constituted a substantial failure to comply with the requirements of 42 C.F.R. � 483.25. Petitioner rebutted the remaining allegations of noncompliance that were made at Tag 309. Petitioner's explanation for delaying administration of antibiotics from the evening of September 3, 2002 until after it had received the results of the urinalysis is plausible and a reasonable explanation for its staff's not immediately beginning to administer antibiotics to Resident # 21. P. Ex. 18; P. Ex. 41, at 15. The resident's physician did not specifically instruct Petitioner's staff as to when to begin administering antibiotics to the resident. P. Ex. 39 at 2. As the resident's nurse explained, absent an instruction that antibiotic administration begin immediately, it was a reasonable exercise of the nurse's judgment to defer beginning to administer antibiotics to the resident until a urinalysis of the resident had been completed. P. Ex. 18; P. Ex. 41, at 15; P. Ex. 39, at 2 - 3.
At Tag 314 of the report of the September survey the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.25(c). CMS Ex. 21, at 10 - 14. This regulation requires that, based on a resident's comprehensive assessment, a facility must ensure that a resident who enters a facility without pressure sores does not develop them unless the resident's clinical condition demonstrates that they were unavoidable. It requires additionally that a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection, and to prevent new pressure sores from developing. The surveyors who conducted the September survey alleged that Petitioner failed to prevent three residents from developing pressure sores. These residents are identified in the survey report as Residents #s 9, 11, and 22. CMS Ex. 21, at 12. Specifically, the surveyors alleged the following:
It is not entirely clear from the survey report or from the evidence offered by CMS whether CMS is alleging that Petitioner failed to prevent residents from developing pressure sores that were avoidable, whether Petitioner failed to treat pressure sores that had developed, or both. However, for sake of analysis, I am assuming that the allegations are that Petitioner failed both to prevent the development of avoidable sores and to treat those sores that its residents developed. The evidence cited by CMS is prima facie proof that both Residents #s 9 and 11 developed injuries to their skin that were observed by surveyors. It is also prima facie proof that Petitioner's staff allowed these injuries to go untreated for at least a full day after the staff was notified by the surveyors about the existence of the wounds. Petitioner has offered no evidence to dispute the surveyors' allegations that the residents had the injuries that are identified in the survey report. Nor has Petitioner offered any evidence to rebut the allegations that it failed to treat these wounds. Rather, Petitioner disputes that these injuries - particularly that which was developed by Resident # 11 - actually constituted pressure sores. It argues that the wound experienced by Resident # 9 was merely an "abrasion." Tr. at 57, 59 - 60. And, it asserts that the injury experienced by Resident # 11 was some sort of traumatic injury to the resident's toe and not a pressure sore. Id. at 60. It contends that it is excused from having to comply with the requirements of the pressure sore regulation insofar as the care given to Residents #s 9 and 11 is concerned if, in fact, the injuries suffered by the residents are not pressure sores. I disagree with Petitioner's analysis. In my judgment it does not matter whether the injuries that were experienced by the two residents met the clinical definition of pressure sores. Indeed, neither party has supplied me with evidence showing what the clinical definition of a pressure sore is, so it would be difficult in any event for me to make findings as to whether these injuries were pressure sores. What does matter is that the facility failed to deal with these wounds at all despite being put on notice by the surveyors that the residents had injuries which could have been pressure sores. The central evidence that CMS offered and which Petitioner did not rebut shows that both Resident # 9 and Resident # 11 had wounds which surveyors - who are trained nurses - identified to be pressure sores and which these surveyors brought to the attention of Petitioner's staff. Notwithstanding, Petitioner had provided no care whatsoever to either of these residents' wounds a full day after the wounds had been brought to its staff's attention. The requirements of 42 C.F.R. � 483.25(c) that a facility take measures to prevent and to treat pressure sores would be rendered largely meaningless if a facility could measure its performance by hindsight. The regulation clearly requires a facility to treat wounds that might be pressure sores as if they are pressure sores. Otherwise, wounds that are in fact pressure sores could go untreated. Here, both Resident # 9 and Resident # 11 had injuries which clearly could have been pressure sores. Indeed, professionally trained nurses concluded that the wounds were pressure sores. Petitioner had an affirmative duty to provide care to these residents as soon as the presence of these possible sores had been brought to its staff's attention. The failure by Petitioner's staff to provide any care to these residents - including a failure to at least consider whether to seek a physician's advice as to whether the injuries were pressure sores and to administer care consistent with the physician's advice - constituted a failure by Petitioner and its staff to take measures to treat the wounds, to promote healing, and to prevent the development of pressure sores in the future. There is no dispute that Resident # 22 - the third resident whose care is at issue under Tag 314 - developed a pressure sore. See P. Ex. 39, at 4. But, Petitioner vigorously takes issue with CMS's apparent assertion that the sore was avoidable. Nor does Petitioner agree that it failed to provide the resident with necessary care. An unavoidable pressure sore is one that develops despite implementation of reasonable measures that are intended to prevent the development of sores. Wellington Specialty Care & Rehabilitation Center, DAB CR548 (1998). Resident # 22 was gravely ill, near death, and it is possible that no level of care would have prevented the resident from developing a pressure sore. On August 23, 2002, Resident # 22 was designated as "DNR" (do not resuscitate) and comfort care only measures were instituted for her. P. Ex. 39, at 4. But, that did not excuse Petitioner's staff from taking reasonable measures designed to prevent the resident from developing pressure sores. Petitioner owed that duty to its residents, including Resident # 22, regardless of the resident's medical condition. It is impossible to say that the sore that the resident developed after August 21, 2002 was unavoidable in light of Petitioner's failure to take measures that were designed to prevent the resident from developing additional sores. Petitioner's staff knew the resident was at risk for developing a pressure sore on her buttock because the resident had a history of having a pressure sore in that area. The evidence offered by CMS - which Petitioner did not rebut - is that Petitioner did not undertake any measures designed to prevent the resident from developing additional sores between August 21, 2002 and September 3, 2002, when the new sore was identified, even though Petitioner's staff knew that the resident was at risk for developing a sore. The fact that the resident was terminally ill and that a physician had issued a "do not resuscitate" order for the resident provides Petitioner with no justification for failing to take reasonable measures that were designed to prevent Resident # 22 from developing additional pressure sores. A diagnosis that a resident has a terminal illness does not excuse a facility from providing needed care.
At Tag 327 of the report of the September survey the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.25(j). CMS Ex. 21, at 14 - 15. The regulation requires that a facility provide each of its residents with sufficient fluid intake to maintain proper hydration and health. The surveyors alleged that Petitioner failed to comply with the requirements of the regulation in that it failed adequately to monitor the fluid intake of a resident who is identified in the survey report as Resident # 14. The surveyors made the following specific allegations to support their overall allegation of noncompliance:
The allegations make out a prima facie case that Petitioner failed to comply with the requirements of 42 C.F.R. � 483.25(j) in providing care to Resident # 14. The evidence offered by CMS shows that this resident had hydration problems. Yet, Petitioner failed to monitor closely the resident's intake and output of fluids. Petitioner does not deny the specifics of the allegations. Instead, Petitioner contends that Resident # 14 was close to death during the time period that CMS asserts that Petitioner's staff were derelict in fulfilling their obligations to the resident. The resident died on August 30, 2002. Petitioner argues that it would have been senseless for its staff to attempt to monitor and to adjust the resident's hydration in light of the resident's condition and the resident's final wishes. I find that Petitioner rebutted CMS's prima facie evidence of noncompliance by the preponderance of the evidence. I do not conclude that a facility has no duty to assure that a terminally ill resident is adequately hydrated. The regulation makes it plain that the duty extends to all residents regardless of their medical condition. But here, compliance with the final wishes of the resident made it impossible for Petitioner to carry out its duties. The evidence shows that, in the final days of the resident's life Resident # 14 asked Petitioner's staff to discontinue the administration of fluids. On August 23, 2002, the resident expressed a desire to no longer have per-mouth intake. The resident refused intravenous fluids as well. P. Ex. 24, at 2. Compliance with those wishes meant that the resident would not receive fluids. Unless the facility were to disregard the resident's wishes and force the resident to consume fluids there was nothing that the facility could do to assure that the resident received adequate hydration. I do not find that the regulation requires a facility to force a resident to consume fluids against the resident's will.
At Tag 329 of the report of the September survey the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.25(l)(1). CMS Ex. 21, at 15 - 17. The regulation provides that the drug regimen of each resident of a facility must be free from unnecessary drugs. It defines an unnecessary drug to be any drug that is used: in excessive dose; or for excessive duration; or without adequate monitoring; or without adequate indications for its use; or in the presence of adverse consequences which indicate that the dose should be reduced or discontinued; or for any combination of the aforesaid reasons. The surveyors alleged that Petitioner's staff failed to assess adequately the need for and to monitor the behaviors of two residents who were taking psychotropic medications. These residents are identified in the survey report as Residents #s 7 and 21. Specifically, the surveyors alleged that:
These allegations establish a prima facie case of noncompliance with the requirements of the regulation. If not rebutted, they show that Petitioner failed to assess or monitor residents in order to determine whether the residents needed to take psychotropic medications. In the absence of such assessments it would be impossible for Petitioner's staff to discharge its duty under the regulation to assure that residents did not receive unnecessary medications. I find that Petitioner did not rebut these allegations. Petitioner failed to show that it was taking meaningful measures to evaluate either of the two residents to determine whether the drug dosages they were receiving were appropriate for their respective conditions. Petitioner argues that both residents received psychotropic medications based on their medical histories and on evaluations and prescriptions by physicians. That may be so, but it begs the question of whether Petitioner fulfilled its obligations to the residents. The regulation imposes a duty on a facility independent of that which is assumed by the resident's physician. Under this regulation the facility's staff is charged with performing a function that augments the physician's care. In assessing its residents for the need for initiating or continuing drug therapy a facility provides the physician with important information that he or she may need to make a judgment about whether to prescribe medication. Here, Petitioner failed to provide that assistance. Second, Petitioner argues that the failures to do initial assessments predated the September survey by several months and that Petitioner should not be held accountable for what its staff failed to do in the remote past. I do not find this argument to be persuasive. The initial failure by Petitioner's staff to do assessments is an element of a pattern of failures by Petitioner's staff to provide needed services for the two residents whose care is at issue. Unlike the case of Resident # 3, which I discuss above, at Finding 2.c., the care that Petitioner gave to the two residents in question was ongoing. If Petitioner's only obligation to the two residents whose care is at issue here was to do an initial assessment for drug needs, I might be persuaded that its failures in the relatively remote past to do such assessments were not meaningful proof of the current state of care at Petitioner's facility. Here, however, Petitioner's failure to do an initial assessment was part of a continuum of failures by Petitioner's staff to monitor and assess the residents. Petitioner argues that, in fact, it did assess the two residents on an ongoing basis for the need for continuing administration of psychotropic medications. It alleges that mental health notes show that Resident # 21 was monitored on a continuous basis. See P. Ex. 28. In fact, the exhibit that Petitioner relies on is a single mental health progress note dated May 21, 2002. It does not show continuous monitoring of the resident. The surveyors alleged that there was no evidence of monitoring in the resident's record after the implementation of a June 18, 2002 care plan which required such monitoring. I find that Petitioner has offered nothing to rebut this allegation. Nor do I find evidence of monitoring of Resident # 7 for the possible adverse effects of psychotropic medication. Petitioner asserts that the resident was assessed on July 31, 2002 and on August 23, 2002 and that worksheets were generated which contained the results of these assessments. See P. Ex. 33, at 1 - 2. However, the worksheets that Petitioner relies on do not address the effects of medications. Id.
At Tag 354 of the report of the September survey the surveyors allege that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.30(b)(1) - (3). CMS Ex. 21, at 17 - 19. In relevant part the regulation requires a facility to designate a registered nurse to serve as its director of nursing on a full time basis. The surveyors alleged that Petitioner did not have a full time registered nurse director of nursing on its staff. They base this conclusion on two assertions:
Petitioner offered proof that, during the week that preceded the September survey, its director of nursing was Kerri Seibold, R.N. P. Ex. 42. Ms. Seibold is a registered nurse who is licensed to practice in the State of Tennessee. Id. Ms. Seibold works for Petitioner in a full-time capacity and regularly works more than 40 hours during the week. She averred that she was absent from Petitioner's facility on September 4 and 5, 2002 to attend a Coast Guard ceremony in Virginia at which her son was participating. Id. at 3. However, during the period of her absence another registered nurse was placed in charge on an acting basis. Id. I find that the evidence offered by Petitioner fully rebuts CMS's allegations. The preponderance of the evidence establishes that Ms. Seibold was Petitioner's full-time, Tennessee licensed, registered nurse director of nursing. There are no requirements in the regulation which require that a "full time" director of nursing work a 40-hour week or which preclude the director of nursing from taking days off. Clearly, an employee can be a "full time" employee and work less than 40 hours and take occasional time off. For this reason, I do not find to be persuasive the surveyors' assertions about Petitioner failing to have a director of nursing who worked a sufficient number of hours. The evidence is more than persuasive that Ms. Seibold functioned on a full time basis and that the hours she missed on September 4 and 5, 2002 were for personal reasons that are entirely consistent with full time employment.
At Tag 490 of the report of the September survey the surveyors alleged that Petitioner failed to comply substantially with the requirements of 42 C.F.R. � 483.75. CMS Ex. 21, at 19 - 22. This regulation provides that a facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each of its residents. The surveyors based their allegations of noncompliance on two assertions. First, they argued that Petitioner's alleged failure to comply with the other eight tags that are cited in the survey report proved that Petitioner was not complying substantially with the requirements of the regulation. Second, they asserted that Petitioner did not allocate adequate staff to meet the needs of its residents. I find that neither of these allegations are supported by prima facie evidence of noncompliance. The record of this case establishes that Petitioner failed to comply substantially with two participation requirements. The evidence of Petitioner's noncompliance is not, in and of itself, sufficient to establish an overall failure by Petitioner to comply with applicable administration requirements. CMS has offered nothing to show a nexus between Petitioner's noncompliance and the way in which it was administered. Nor has CMS offered any prima facie proof to show that Petitioner assigned inadequate numbers of staff to meet the needs of its residents. The allegation that Petitioner's failures to provide care in accordance with applicable regulatory requirements are due to inadequate staffing by Petitioner is simply speculation in the absence of some concrete proof that Petitioner did not assign enough staff to meet its residents' needs.
As I discuss above, at Finding 1, CMS is authorized to terminate a facility's participation in Medicare based on the presence of even a single failure by that facility to comply with applicable participation requirements. The evidence in this case establishes that Petitioner failed to comply with two participation requirements. That is more than enough grounds for CMS to terminate Petitioner's participation in Medicare. |
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JUDGE | |
Steven T. Kessel
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